Bob deals with the underlying nature of HACCP and its meaning in relation to fresh food:

In the PMA-United merge article in the 10.27 Pundit, I read: “The bottom line on this crisis is that the FDA’s action to impose a blanket recommendation not to consume spinach bespeaks very weak relations with the produce industry. It implies little confidence in the trade and it implies that our government relations efforts haven’t been particularly effective.”

This may be actually the bottom line, but there is another line which I think might be even more bottom, which is: given the underlying criteria for HACCP (or, more exactly, the way in which these criteria are widely interpreted), all fresh food is inherently unsafe. You have touched on this in some of your articles.

Specifically, the problem is how “critical control” is understood. The FDA and USDA both define it as eliminating a risk or reducing it to an acceptable level. Since no one in any public position can ever propose that there is an acceptable level of illness, what this means is that there is basically a zero tolerance for risk.

Another underlying piece is that this “control” is widely understood to be a treatment solution of some sort, since prevention at the source, and testing at some later point, cannot possibly reduce a risk to zero. (In terms of produce, read: irradiation.)

A third aspect of this is that the bigger the producer, the more inevitable it becomes that smaller likelihoods of risk become more and more inevitable.

It could be argued (in fact, I’ll argue it!) that the consolidation of production and processing has directly contributed to all this concern about food safety. This may have started back with Upton Sinclair. So the question should be asked: Will combining PMA and UFFVA help take the heat off, or will it do just the opposite?

Consider the situation with raw milk, which is today synonymous with unacceptable risk, and is illegal to sell in many locations. 100 years ago, this idea would have been laughable. Are we headed to a world where it will be illegal to sell non-pasteurized produce? If so, who will own the food supply?

Quite a quandary...

Indeed. Bob ties together an important line of thinking. In our piece on the Town Hall Meeting on spinach, which was held at the PMA convention in San Diego, we expressed the frustration of the industry in listening to regulators talk:

What, precisely, is the food safety standard that the government wants the industry to implement? As public health authorities, the regulators can’t be “special prosecutors,” consumed with spinach as the only threat to public health. They need to be mindful of the allocation of funds in society. They also need to be mindful of the substitution effect. As prices rise for an item such as spinach, an item recognized by public health authorities as healthy, people substitute other foods. If those foods are less healthy than spinach, then we could reduce fatalities from spinach and increase total fatalities as people die from the consequences of eating unhealthy substitutes.

Beyond lip service, however, the regulators showed no willingness to wrestle with these hard questions. Five people are believed to have died in the last ten years as a consequence of these matters in lettuce and spinach. In the same period, however, the industry produced over a trillion servings of these products — so by any reasonable standard, the product is enormously safe.

It can, however, always be made safer. And the question is what is the regulatory position on additional expenditures to achieve safety?

If we determine that by spending an extra $100 million a year, we can reduce fatalities by 20% — so spend a billion dollars in the next ten years and four people will die. Should we do it? What do the regulators want? What if we determine that by spending $250 million a year or $2.5 billion over the next ten years, we could reduce deaths by 40% — so three people would die over the next decade? Is that the regulator’s preference? Suppose the only way to get deaths down to zero is to grow everything in greenhouses. And imagine this costs $500 million a year or $5 billion over the next decade. Is that what the regulators want?

And how do they know that when the spinach industry is finally getting awards from the FDA for food safety that the higher prices of greenhouse-grown produce won’t lead more people to eat hamburger or chicken and that total fatalities in society won’t increase as people sometimes don’t cook these things properly and they die from E. coli and Salmonella and obesity-related diseases?

The regulatory community has a responsibility to not merely express generalized desires for “safe” product but to express, clearly, how they want these necessary trade offs to be made. They didn’t do this at the “Town Hall” meeting and, absent such an explanation, the industry has no reliable guide to making the real-world decisions that have to be made.

Bob is answering this frustration by basically saying “don’t hold your breath,” waiting for the regulators to wrestle with any of these real world questions. As Bob explains:

“Since no one in any public position can ever propose that there is an acceptable level of illness, what this means is that there is basically a zero tolerance for risk.”

The industry mechanism for establishing the safety of our products is HACCP (Hazard Analysis Critical Control Points) plans, but as Bob explains:

“…given the underlying criteria for HACCP (or, more exactly, the way in which these criteria are widely interpreted), all fresh food is inherently unsafe. You have touched on this in some of your articles.”

Indeed we have been harping on the fact that we should stop saying that our food is “safe,” since the term has no meaning. One can always make the product safer.

But Bob points out something else:

Specifically, the problem is how “critical control” is understood. The FDA and USDA both define it as eliminating a risk or reducing it to an acceptable level. Since no one in any public position can ever propose that there is an acceptable level of illness, what this means is that there is basically a zero tolerance for risk.

Another underlying piece is that this “control” is widely understood to be a treatment solution of some sort, since prevention at the source, and testing at some later point, cannot possibly reduce a risk to zero. (In terms of produce, read: irradiation.)

Put another way, if the FDA is unwilling to say that any amount of illness is acceptable and no amount of effort in prevention can reduce the risk to zero, you need a critical control step that will reduce the risk to zero. Irradiation is the classic example.

Bob further points out that the problem gets worse as the firms in the trade get larger:

It could be argued… that the consolidation of production and processing has directly contributed to all this concern about food safety. This may have started back with Upton Sinclair. So the question should be asked: Will combining PMA and UFFVA help take the heat off, or will it do just the opposite?

Actually, Bob is slightly off here. The problem is perceived to get worse because of the statistical mirage that identifies food safety outbreaks from large producers and can’t trace them back to small producers. But from an industry PR angle, his point is correct.

We do think the analogy to United/PMA is a little strained. Consolidation on the production end actually changes both food safety, because bigger companies have different procedures, etc., and it changes the traceability of a product. Whether associations are large or small affects nothing — except depending on the relative effectiveness of a consolidated entity vs. two entities.

Which is the real subject under discussion.

This issue of zero acceptance of risk strikes us as the crucial issue. It forces our representatives at trade associations into some kind of weird Kabuki like ballet with regulators in which nobody wants to admit the truth: We can discuss enhanced food safety efforts but crops are inherently vulnerable and total safety cannot be guaranteed.

To say we will do everything “humanly possible” to insure safety is meaningless because we can always do more.

If we are going to continue with field-grown crops, we have to move the regulators and society at large to a different perception of acceptable risk.

Rick Russo of Tanimura & Antle provided an interesting perspective:

Excellent commentary on the status of regulator’s positioning on food safety for the produce industry. When you mentioned the “analogy” to 9/11 and the uncertainty of air safety, it made me think. The commercial aviation industry operates under federal regulation with a permanent uncertainty of safety. In fact, the target rate of fatal incidents established by FAA is .018 per 100,000 departures. (link below)

Based on your estimate of a trillion serving of lettuce and spinach over the last ten years, and a known fatality rate of 5, our industry’s fatality rate per 100,000 servings is .0005, or 360 times lower. Never mind the fact that FAA is measuring “incidents” vs. individual fatalities. Other than post-9/11, the FAA has never shut down the entire aviation industry after an incident. Even in the case of 9/11, flights were resumed in 48 hours. FDA took 18 days to ease their consumer warnings on eating spinach which, as you say, was an effective shutdown.

Anyhow, just wanted to say thanks for speaking up. Wish somehow we could get national press similar to yours.

Appreciate the kind words Rick, the Pundit is pretty thoroughly reviewed by many major media outlets and back at Pundit Central, we field calls almost every day from consumer media looking to understand the industry better — so we are having an impact not always fully appreciated. Kind of a little service we do to help the trade.

The link Rick gives us is excellent, and you should look at the charts. I’ll just excerpt a little copy regarding the way the Federal Aviation Administration (FAA) talks about safety:

The goal for the end of the fiscal year is a three-year rolling average of 0.018 fatal accidents per 100,000 departures. Through March of this year, the aviation industry has maintained a rate of 0.022 fatal accidents per 100,000 departures. There have been three fatal air carrier accidents this fiscal year. On December 8, 2005, a Southwest Airlines 737 overran a runway in Chicago (Midway). The aircraft then hit a car, killing a child inside. No passengers or crew were killed. The second, on December 15, 2005, was a twin-engine Grumman G-73T Turbine Mallard turboprop seaplane operated by Chalks International Airlines. The aircraft crashed into the water shortly after takeoff from Miami, Florida. Eighteen passengers and two crewmembers died on the flight. The third, on January 16, 2006, involved a mechanic ingested into the engine of a Continental Airlines jet. The FAA continues its work that has resulted in the almost continuous long-term reduction of the commercial air carrier fatal accident rate. We will make our FY 2006 goal of a rate no higher than 0.018 fatal accidents per 100,000 departures if we experience no more fatal accidents in FY 2006.

This presents a much more reasonable approach to risk than the absolutism of the FDA. They actually set a goal for the number of fatal incidents — .018 fatal accidents per 100,000 departures — and Rick is far more generous than the Pundit when he says “Never mind the fact that FAA is measuring ‘incidents’ vs. individual fatalities.” Remember that an “incident” might involve hundreds of fatalities. It is also a bit unclear from the material, but they may also exempt from their calculations acts of terrorism.

Still if the regulators on aviation can accept the idea of managing policy to reduce fatalities and consumers are willing to still fly planes, maybe the whole way we look at risk on field-grown crops needs to be reexamined.

It is hard to sustain a fiction, and it is a fiction that anything we do in food safety will produce 100% assurance of safety. Since this is true, the question is how do you build a regulatory framework that acknowledges this fact and how do you communicate to the consumer that though there are risks, they are infinitesimal?